Abstract

DNA-based molecular testing for Human Papillomavirus (HPV) has emerged as a novel approach to cervical cancer screening in the context of well entrenched prior technology, the Pap smear. This paper seeks to elucidate the process of molecularisation (Clarke et al. 2003) in the context of screening programmes. We illustrate how, although Pap has long been problematised and could be seen as a competing technological option, the existing networks, and regime for Pap were important in supporting the entrenchment process for the artefacts, techniques, and new diagnostics industry entrant Digene, associated with the new test. The paper provides insights into how molecularisation of screening unfolds in a mainstream market. We reveal an incremental, accretive, rather than revolutionary process led by new commercial interests in an era when diagnostic innovation is increasingly privatised. We show Digene's reliance on patents, an international scientific network, and their position as an obligatory passage point in the clinical research field with regard to the new technology's role, as well as controversial new marketing practices. The paper is based on a mixed method approach, drawing on a wide range of contemporary sources (including patents, statutory filings by companies, scientific literature, and news sources) as well as interviews.